Multimodal Analgesia Utilization and Acute Postoperative Pain After Major Surgery at Mulago National Referral Hospital

NCT06887153 | Recruiting

• 1 other identifier: MAK-SOMREC-2024-920
• Study Type: observational
• Target: 449
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to understand the approach to pain management before, during, and after surgery at Mulago National Referral Hospital. It is focussed on adult patients undergoing major surgery. The main questions it aims to answer are:

• How often are combinations of pain medications utilised before, during and after surgery?
• Do combinations of pain medications result in better pain control after surgery compared to single pain medications? Information on pain medications will be obtained from patient records. Patients will be asked to rate their pain after surgery every 6 hours for 24 hours.

Conditions

Pain

Keywords

Perioperative; Multimodal Analgesia; Acute Postoperative Pain; Major Surgery

Outcome Measures

Primary Outcomes (1)

• patient-reported acute postoperative pain levels

  This will be measured using an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain). Pain intensity will be graded as mild (NRS: 1-3), moderate (NRS: 4-6), and severe (NRS: 7-10).

  Postoperative pain will be assessed at 0, 6, 12, 18, and 24 hours postoperatively.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present for surgical treatment at Mulago National Referral Hospital, Kampala City, Uganda

You may qualify if:

• Patients ≥18 years
• Scheduled for elective orthopaedic, abdominal and thoracic surgeries
• In the selected operating theatres during the study period

You may not qualify if:

• Reduced levels of consciousness or neurological deficits
• ASA \>III

Sponsors & Collaborators

• Makerere University: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Mulago National Referral Hospital

Kampala, Uganda

RECRUITING

MeSH Terms

Conditions

Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Emmanuel S. Aporu, MBChB

  Makerere University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel S. Aporu, MBChB

CONTACT

+256 758662377; aporu1994@gmail.com

Peter K. Agaba, MBChB, MMed

CONTACT

Kaahwa39@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: August 8, 2024
• Primary Completion: June 17, 2025
• Study Completion: July 17, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 6 months after publication upto 2 years after publication
• Access Criteria: Request must be reasonable. In case of intended statistical analyses, an institutionally approved proposal must be presented.

Locations

UG (1)